Prostar XL Percutaneous Vascular Surgical Device

Transcription

1 Clinical leader for percutaneous large access site closure Close Access Sites Up to 24F Secure Closure Prostar XL Percutaneous Vascular Surgical Device Improved Outcomes 2009 Abbott Laboratories. All rights reserved. EHQ /2009

2 KNOT PUSHER Marker Lumen Suture Lumens Star Hub Handle Interlocks Marker Port Barrel Guide Wire Exit Port Sutures Nitinol Needles Sheath 2

3 MARKING Suture Lumens Marker Lumen 45º 360º Hub Marker Port Unlock the Hub by depressing the Interlocks with the thumb and forefinger. Once the Hub is unlocked, rotate the Hub while gently advancing the barrel at a 45º angle. A steady, continuous drip of blood from the Marker Lumen occurs when the Prostar Device is properly positioned. Marking from the Suture Lumens may occur but should not be used as an indicator for proper positioning. 3

4 NEEDLE DEPLOYMENT Pulsatile Marking Marker Lumen Needle Tips STAR Hub Handle Suture Lumens 45º 4 Visually confirm that the STAR embossed on the hub is at the 12-o'clock position during deployment. Confirm that the Interlocks are re-engaged and correctly aligned with the locking indents in the Hub. Hold the Hub of the Prostar Device in position with the left hand while deploying needles with the right hand. Maintaining a 45 degree angle, rotate the handle counter-clockwise 90º and pull the handle straight back away from the Hub to deploy the needles. If needles are not easily deployed, back the needles down into the sheath prior to device removal.

5 NEEDLE REMOVAL Hub Verify that all needles are present. Using the Hub as a fulcrum, remove the posterior needles first. 5

6 BOWSTRINGING Sheath Apply tension to suture ends Sheath should be bent outward away from the operator. Grab the suture adjacent to the sheath and pull the ends through the distal end of the barrel. 6

7 PRE-CLOSE TECHNIQUE Anterior Sutures Posterior Sutures Interarterial view of sutures with one device Access sites larger than 10F require the use of the pre-close technique (placement of the Prostar XL device sutures prior to dilating the access site beyond 10F) When utilizing a pre-close technique, the Prostar XL device is exchanged for an appropriately sized introducer sheath or additional Prostar XL device if additional sutures are to be placed around the same access site. 7

8 SECOND DEVICE PLACEMENT 45 rotation Sutures from First Device STAR Interarterial view of sutures with two devices Access sites larger than 10F may require the use of an additional device. If additional sutures are to be placed, position an additional Prostar XL device rotated 45 degrees relative to the first Prostar XL device to establish alternating suture positions. 8

9 SECOND DEVICE SUTURE MANAGEMENT Sutures from Second Device Sutures from First Device Identify and secure the sutures from the first device separately from the sutures of the additional device. 9

10 KNOT TYING Non-Rail Non-Rail Non-Rail Non-Rail Non-Rail Rail Rail Rail Rail Rail 1 To tie a knot, place a hemostat between both suture tails. 2 Decide which tail will be the rail (slides knot) and non-rail (knot). Wrap the non-rail around the rail five (5) times. 3 Place the tip of the non-rail through the loop you created with the hemostats. This creates a second loop. 4 Now place the tip of the non-rail tail through the second loop. 5 You can remove some of the slack in the knot by pulling gently on the non-rail being careful not to pull too tightly. Remove the hemostats. 6 As you remove slack, do not pull too tightly or you will lock the knot. If the knot is locked prematurely, you will not be able to advance the knot. To advance the knot using the Knot Pusher, securely wrap the rail around your left index finger. 10

11 PRE-CLOSE TECHNIQUE KNOT TYING When utilizing a pre-close technique, sliding, self-locking surgical knots should be tied prior to introducer sheath removal. Sutures should be gradually tightened as the introducer sheath is removed to maintain hemostasis. 11

12 KNOT PUSHER USAGE Thumb Knob Window Suture Retract the Thumb Knob on the handle and position the suture across the window located at the distal end of the Knot Pusher. Release the Thumb Knob to load the suture. 12

13 SINGLE HAND KNOT ADVANCEMENT White suture is closest to artery Interarterial view of sutures with one device White suture of first device is closest to artery Interarterial view of sutures with two devices The White Suture must be tied first because it is the closest suture to the artery. If using an additional, the white suture of the first device should be tied first, followed by green and repeated for the second device. This step eliminates the possibility of trapping the White Suture. To avoid an air knot apply tension to the suture while advancing the knot. Tension must be applied to remove slack in the suture while advancing the knot. 13

14 HEMOSTASIS Apply constant, gentle pressure to the Knot Pusher and pull on the suture wrapped around index finger until hemostasis is achieved. Remove guide wire before locking the knot. Alternate between the green and white sutures to achieve hemostasis. Once hemostasis is achieved, trim the sutures below the skin. 14

15 NEEDLE BACKDOWN Needles LATERAL VIEWS Radiopaque Sheath Ring If needles are not easily deployed, back the needles down into the sheath prior to device removal. Use cine to identify the position of the needle tips, prior to backing down the needles. Use a needle holder to grasp the pull rod a few millimeters proximal to their exit from the device core. Manually remove the coiled sections of the suture lumens to uncover the suture loops. Gently feed the pull rod back into the core and gently pull the slack out of the uncovered suture loops one centimeter at a time until the handle snaps. Verify that the needle tips are as close as possible to the proximal edge of the radiopaque sheath ring prior to device removal. Rotate the handle counterclockwise 90 degrees to lock back to the initial position 15

16 Prostar XL is a trademark of the Abbott Group of Companies. Please contact your local representative for more information. Abbott Vascular International BVBA Park Lane Culliganlaan 2B, 1831 Diegem BELGIUM This product in intended for use by or under the direction of a physician. Prior to use, it is important to read the package insert thoroughly for instructions for use, warnings and potential complications associated with use of this device. Information contained herein for distribution outside the U.S. and Japan only. Please check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force. For more information, visit our website at abbottvascular.com 2009 Abbott Laboratories. All rights reserved. EHQ /2009